Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
Public ClinicalTrials.gov record NCT04604652. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2 Open Label, Proof of Concept Study of HTD1801 (BUDCA) in Adult Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to Standard Therapy - PRONTO-PBC
Study identification
- NCT ID
- NCT04604652
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- HighTide Biopharma Pty Ltd
- Industry
- Enrollment
- 24 participants
Conditions and interventions
Conditions
Interventions
- HTD1801 (BUDCA) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 26, 2021
- Primary completion
- May 30, 2022
- Completion
- May 30, 2022
- Last update posted
- Apr 23, 2024
2021 – 2022
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Miami Schiff Center for Liver Disease | Miami | Florida | 33136 | — |
| Piedmont Healthcare | Atlanta | Georgia | 30309 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Henry Ford Health Services | Detroit | Michigan | 48202 | — |
| St. Louis University | St Louis | Missouri | 63104 | — |
| Northshore University Hospital | Manhasset | New York | 11030 | — |
| University GI | Providence | Rhode Island | 02905 | — |
| Baylor Research Institute | Dallas | Texas | 75246 | — |
| The Texas Liver Institute | San Antonio | Texas | 78215 | — |
| Liver Institute of Virginia | Newport News | Virginia | 23602 | — |
| Bon Secours Liver Institute of Richmond | Richmond | Virginia | 23226 | — |
| Liver Institute Northwest | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04604652, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 23, 2024 · Synced May 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04604652 live on ClinicalTrials.gov.